Ultraviolet Light Therapy Using Methoxsalen With or Without Bexarotene in Treating Patients With Mycosis Fungoides
- Conditions
- Lymphoma
- Interventions
- Registration Number
- NCT00056056
- Brief Summary
RATIONALE: Ultraviolet light therapy uses light and drugs that make cancer cells more sensitive to light to kill tumor cells. It is not yet known whether ultraviolet light therapy is more effective with or without bexarotene in treating mycosis fungoides.
PURPOSE: Randomized phase III trial to compare the effectiveness of ultraviolet light therapy using methoxsalen with or without bexarotene in treating patients who have mycosis fungoides.
- Detailed Description
OBJECTIVES:
* Determine if ultraviolet A light therapy with methoxsalen (PUVA) with or without bexarotene yields a significantly higher overall response rate in patients with mycosis fungoides.
* Compare the overall response rate (CCR and partial response) in patients treated with these regimens.
* Compare the duration of CCR and time to relapse of patients treated with these regimens.
* Compare the number of PUVA sessions necessary to achieve a CCR in these patients.
* Determine the percentage of dropouts by patients treated with these regimens.
* Determine the safety of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to participating center, age (60 and under vs over 60), and stage of disease (IB vs IIA). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive PUVA comprising oral methoxsalen given 2 hours before whole body ultraviolet A therapy. PUVA is given 3 times per week.
* Arm II: Patients receive oral bexarotene once daily and PUVA as in arm I. In both arms, treatment repeats for up to 16 weeks in the absence of complete clinical response, disease progression, or unacceptable toxicity.
Patients are followed every 8 weeks until the first documented progression or relapse.
PROJECTED ACCRUAL: A total of 145 patients will be accrued for this study within 25 months.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 93
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Bexarotene and PUVA methoxypsoralen - Bexarotene and PUVA UV light therapy - PUVA methoxypsoralen - PUVA UV light therapy - Bexarotene and PUVA bexarotene -
- Primary Outcome Measures
Name Time Method Overall response rate (complete clinical response [CCR) and partial response [PR]) 35 months after first patient in
- Secondary Outcome Measures
Name Time Method Cumulative dose of UVA required to achieve CCR 35 months after first patient in Number of PUVA sessions necessary to achieve a CCR 35 months after first patient in Duration of CCR as measured by Logrank every 4 weeks during treatment and then every 8 weeks until progression 35 months after first patient in Time to relapse 35 months after first patient in Safety as assessed by CTC v2.0 every 4 weeks during treatment, then every 8 weeks 35 months after first patient in Percentage of dropouts as measured by the percentage of cases not completing treatment due to toxicity at the completion of treatment 35 months after first patient in
Trial Locations
- Locations (28)
CHR Hotel Dieu
🇫🇷Nantes, France
Hospital Universitari de Bellvitge
🇪🇸Barcelona, Spain
Allgemeines Krankenhaus - Universitatskliniken
🇦🇹Vienna, Austria
U.Z. Gasthuisberg
🇧🇪Leuven, Belgium
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Klinikum der Stadt Mannheim
🇩🇪Mannheim, Germany
Hospital Universitario Insular de Gran Canaria
🇩🇪Tuebingen, Germany
Southwest German Cancer Center at Eberhard-Karls-University
🇩🇪Tuebingen, Germany
Karl-Franzens-University Graz
🇦🇹Graz, Austria
Ghent University
🇧🇪Gent, Belgium
Bispebjerg Hospital
🇩🇰Copenhagen, Denmark
Helsinki University Central Hospital
🇫🇮Helsinki, Finland
Klinikum Minden
🇩🇪Minden, Germany
Spedali Civili di Brescia
🇮🇹Brescia, Italy
Semmelweis University
ðŸ‡ðŸ‡ºBudapest, Hungary
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
🇩🇪Wuerzburg, Germany
County Hospital
ðŸ‡ðŸ‡ºKaposvar, Hungary
Universita di Torino
🇮🇹Turin, Italy
Rabin Medical Center - Beilinson Campus
🇮🇱Petah-Tikva, Israel
Istituto Dermopatico Dell' Immacolata
🇮🇹Rome, Italy
Leiden University Medical Center
🇳🇱Leiden, Netherlands
Hospital de la Santa Cruz i Sant Pau
🇪🇸Barcelona, Spain
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
UniversitaetsSpital Zuerich
🇨ðŸ‡Zurich, Switzerland
St. Thomas' Hospital
🇬🇧London, England, United Kingdom
Royal Infirmary of Edinburgh at Little France
🇬🇧Edinburgh, Scotland, United Kingdom
Hospital Universitario Nuestra Senora de la Candelaria
🇪🇸Santa Cruz de Tenerife, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain